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Clinical Observation on the Treatment of Diabetic Peripheral Artery Disease (PAD) with Qihuangjuyu Formula Combined with Electroacupuncture

Clinical Observation on the Treatment of Diabetic Peripheral Artery Disease (PAD) with Qihuangjuyu Formula Combined with Electroacupuncture

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000370
Enrollment
Unknown
Registered
2026-02-13
Start date
2022-01-01
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Limb Arteriosclerosis

Interventions

Control Group:In addition to basic treatments such as dietary therapy, smoking cessation, blood sugar control, blood pressure reduction, lipid regulation, antiplatelet therapy, and appropriate exercis
Traditional Chinese Medicine Group:In the control group, on the basis of routine treatment, the Qihuang Juyu formula (Astragalus membranaceus 20g, Polygonatum sibiricum 12g, Carthamus tinctorius 12g,
Electroacupuncture Group:In the control group, on the basis of routine treatment, acupuncture was performed using 0.30×40mm acupuncture needles at bilateral Neiguan, Quchi, Hegu, Zusanli, Xuehai, and
Acupuncture-Medication Combined Group:In the control group, on the basis of routine treatment, the Qihuang Juyu formula was administered once daily, with 400ml of decoction obtained by boiling and tak

Sponsors

Hebei Provincial Traditional Chinese Medicine Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 70 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: (1) Meets the diagnostic criteria for type 2 diabetes. (2) Belongs to the II stage of patients diagnosed with DAO according to Western medical diagnostic criteria. (3) Meets the diagnostic criteria for blood stasis syndrome in traditional Chinese medicine (TCM) differential diagnosis. (4) Aged between 40 and 70 years old. (5) Has signed the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Lower extremity pain, numbness, coldness, etc., caused by vascular or non-vascular diseases. (2) Patients with severe primary diseases involving organs (heart, brain, liver, kidney), hematopoietic system, endocrine system, or mental health issues. (3) Individuals with an allergic constitution or a history of allergy to any components of the study drug. (4) Women who are pregnant, breastfeeding, or intending to become pregnant. (5) Patients currently using Chinese or Western medicine for this condition or participating in other drug trials within the past two weeks. (6) Patients with significantin the TCM syndrome differentiation (blood stasis syndrome). (7) Patients with uncontrollable bleeding disorders, coagulation disorders, a tendency to bleed, or active bleeding within the past two weeks. (8) Patients who have undergone major surgery or significant trauma within the past two months.

Design outcomes

Primary

MeasureTime frame
Total Cholesterol;Triglycerides;Low-Density Lipoprotein ;High-Density Lipoprotein;Tumor Necrosis Facto;Interleukin-1 (IL-1);Interleukin-6 (IL-6);Ankle-Brachial Index (ABI);Toe-Brachial Index (TBI);Superoxide Dismutase (SOD);Malondialdehyde (MDA);Total Antioxidant Capacity (TAC);Nitric Oxide (NO);Endothelin-1 (ET-1);

Secondary

MeasureTime frame
Pain Level in the Affected Limb;Numbness Level in the Affected Limb;Skin Temperature of the Affected Limb;Skin Color of the Affected Limb;Claudication Distance;

Countries

China

Contacts

Public ContactSun Yunchao

Hebei Provincial Traditional Chinese Medicine Hospital

longge202101@163.com15100111981

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Mar 14, 2026